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Colonoscopy Preparation Optimization for INpatients- COIN Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by St. Joseph's Healthcare Hamilton
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Khurram Khan, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01627171
First received: June 19, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.


Condition Intervention Phase
Endoscopy
Bowel Preparation Solutions
Drug: Bisacodyl 10mg
Drug: Polyethelene Glycol
Drug: Picosulfate sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ] [ Designated as safety issue: No ]
    Using a standardized, validated score for measuring quality of bowel preparation


Secondary Outcome Measures:
  • Procedures Cancelled or repeated due to inadequate bowel preparation [ Time Frame: During admission (average of 2 weeks) ] [ Designated as safety issue: No ]
    If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled

  • Individual Components of Ottawa Bowel Prep Score [ Time Frame: 30 minutes after procedure ] [ Designated as safety issue: No ]
    Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually

  • Adverse Effects [ Time Frame: Up to 48 hours after procedure ] [ Designated as safety issue: Yes ]
    Any adverse effects that may be attributed to the intervention

  • Tolerability of the preparation [ Time Frame: Within 1 day of intervention ] [ Designated as safety issue: No ]
    A questionnaire to assess the overall tolerability of the preparation.


Estimated Enrollment: 126
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEG Lyte
PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy.
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Polyethelene Glycol
280g reconstituted in 4 liters of water
Other Name: PEG-Lyte
Experimental: Pico Salax Split
Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy.
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Picosulfate sodium
Two sachets, Each sachet has 10mg dose
Other Name: Pico-Salax
Experimental: Pico Salax Night Before
2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy
Drug: Bisacodyl 10mg
Given at the start of the bowel preparation the day before colonoscopy
Drug: Picosulfate sodium
Two sachets, Each sachet has 10mg dose
Other Name: Pico-Salax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatient colonoscopy
  • Age greater than 18 years old
  • Able to give consent

Exclusion Criteria:

  • No consent obtained
  • Pregnancy or lactating
  • Renal impairment
  • Severe CHF (NYHA class 3/4)
  • Recent myocardial infarction (preceding 6 months)
  • Ileus
  • Ascites
  • Severe Colitis
  • Toxic Megacolon
  • Gastrointestinal Obstruction
  • PEG tube
  • Previous large bowel resection
  • Allergy to study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627171

Contacts
Contact: Lisa Balogh Melanson, BSc 905-522-1155 ext 33673 lbalogh@stjosham.on.ca

Locations
Canada, Ontario
St Joseph Hospital Recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Lisa Balogh-Melanson, BSc    905-522-1155 ext 33673    lbalogh@stjosham.on.ca   
Principal Investigator: Khurram J Khan, MD,BSc         
Sub-Investigator: David Morgan, MD, MSc         
Sub-Investigator: Robert Spaziani, MD         
Sub-Investigator: Subhas Ganguli, MD, MSc         
Sub-Investigator: Keith Tsoi, MD         
Sub-Investigator: Subash Jalali, MBBS         
Sub-Investigator: Houssein Fergani, MD         
Sub-Investigator: Abbas Merali, MD         
Sub-Investigator: Nauzer Forbes, MD         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
Principal Investigator: Khurram J Khan, MD, BSc St Josephs
  More Information

No publications provided

Responsible Party: Khurram Khan, Assistant Professor of Medicine, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01627171     History of Changes
Other Study ID Numbers: RP 12-3657
Study First Received: June 19, 2012
Last Updated: January 28, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014